New FDA User Fee agreement
By Dr Nicola Davies
On August 18, 2017, US President Donald Trump signed into law the Food and Drug Administration Reauthorization Act (FDARA) of 2017, extending the user fee program that was to expire on September 30, 2017.1 This legislation includes the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and the General Drug User Free Amendments (GDUFA).
What is the FDARA 2017?
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